RecruitingPHASE3INTERVENTIONAL

Outpatient Treatment With Anti-Coronavirus Immunoglobulin

This study, called OTAC, is looking into a potential new treatment for adults who have recently tested positive for COVID-19 but aren't sick enough to need hospitalisation. The treatment being tested is called anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG). Participants will receive either hIVIG or a placebo (a dummy treatment) through a drip. Researchers will then compare how people's COVID-19 symptoms progress over seven days to see if hIVIG helps prevent the illness from becoming more serious. The study is designed to be 'double-blind,' meaning neither the participants nor the doctors will know who is receiving the actual treatment and who is receiving the placebo. This helps ensure the results are as fair and unbiased as possible.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Minnesota

Enrolment target

820

Start

06 Aug 2021

Estimated completion

01 Aug 2026

COVID SARS-CoV2 Infection Covid19

What is this study about?

This study, known as OTAC (Outpatient Treatment with Anti-Coronavirus Immunoglobulin), is exploring a new way to help people who have recently caught COVID-19. It focuses on adults who have a positive test result and some symptoms, but are not ill enough to be admitted to hospital. The main goal is to see if a special treatment called anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) can prevent COVID-19 from getting worse and becoming severe, compared to a dummy treatment (placebo). The hIVIG treatment is basically a concentrated dose of protective antibodies that have been collected from people who have recovered from COVID-19, offering a potential boost to the body's natural defences.

The researchers want to understand how safe hIVIG is and if it can improve how quickly people recover or stop them from becoming very unwell. They will carefully monitor participants for seven days after they receive either hIVIG or the placebo. They'll assess various aspects of how a person is feeling and how their COVID-19 is progressing, ranging from no symptoms at all to very severe illness or even death. This helps them get a complete picture of the treatment's effect. The study involves two groups of participants: those who only receive the hIVIG or placebo, and a smaller group who also receive other standard COVID-19 treatments alongside the study treatment.

This type of study is called a 'Phase 3' trial, which means it's one of the final steps before a new treatment might be considered for wider use. It's carefully designed to ensure reliable results by being 'double-blind' – meaning neither the patient nor their doctor knows whether they get the hIVIG or the placebo. This rigour helps ensure any observed benefits are truly due to the hIVIG and not other factors, ultimately aiming to find effective ways to manage COVID-19 and reduce its impact on people's health.

Key takeaways

This study is testing an antibody treatment (hIVIG) for early COVID-19.
It aims to see if hIVIG can prevent severe illness in non-hospitalised adults.
Participants will receive either hIVIG or a dummy treatment (placebo) via a drip.
The study is 'double-blind' – neither you nor your doctor will know which treatment you receive.
Participation involves monitoring your health for 7 days, with overall follow-up for 28 days.
You must have recently tested positive for COVID-19 and have related symptoms to be eligible.

Who may be eligible?

To join this study, you generally need to be an adult (18 years or older) who has recently tested positive for COVID-19 within the last five days, and also started feeling symptoms within the last five days. You also need to meet one of the following criteria: either you are 55 years old or older, or you are an adult with a medical condition that affects your immune system (e.g., if you take strong medications that suppress your immune system or have certain long-term health conditions). You must not need immediate hospital care for COVID-19.

There are also some reasons why you wouldn't be able to join. For instance, if you are currently completely free of COVID-19 symptoms and have been for over a day, or if you've already had a COVID-19 vaccination (since the study is about preventing severe illness in unvaccinated individuals or those newly infected). You also can't take part if you have signs of pneumonia or low oxygen levels because of COVID-19, as the study focuses on earlier stages of the illness. You also can't be taking part in another COVID-19 treatment trial at the same time.

Importantly, participating means you agree not to take part in any other COVID-19 treatment research for at least 7 days, or until your condition changes significantly. You will also need to provide your written consent, showing you understand the study and agree to follow its procedures for about a month.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Did you test positive for COVID-19 within the last 5 days?
Did your COVID-19 symptoms start within the last 5 days?
Are you 55 or older, OR do you have a condition affecting your immune system?
Are you NOT currently needing hospital treatment for COVID-19?
Are you NOT participating in another COVID-19 treatment trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single infusion (a drip into your arm) of either the study treatment (hIVIG) or a placebo (a dummy treatment). This is done on an outpatient basis, meaning you wouldn't be admitted to the hospital for this part. After the infusion, the study involves follow-up assessments to monitor your health and how your COVID-19 is progressing. You'll be regularly checked to see how your symptoms change over seven days after the infusion. The overall monitoring for the study continues for about 28 days to gather all necessary information.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a treatment that could help prevent your COVID-19 from becoming more severe and reduce the risk of needing hospital care, if hIVIG proves to be effective. However, there are also potential risks; you might experience side effects from the hIVIG infusion, or you might receive the placebo and not the active treatment. All medical procedures carry some level of risk, and these will be fully explained before you decide to participate. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (66)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Southern Arizona VA Healthcare System (074-009)
Verified postcode
Tucson, United States· Terminated
VA Northern California Health Care System (074-023)
Verified postcode
Mather, United States· Terminated
Stanford University Hospital & Clinics (Site 203-003)
Verified postcode
Palo Alto, United States· Recruiting
San Francisco VAMC (Site 074-002)
Verified postcode
San Francisco, United States· Terminated
Rocky Mountain Regional VA Medical Center (074-010)
Verified postcode
Aurora, United States· Terminated
MedStar Health Research Institute
Verified postcode
Washington D.C., United States· Withdrawn
Washington DC Veterans Affairs Medical Center
Verified postcode
Washington D.C., United States· Withdrawn
University of Maryland Medical System
Verified postcode
Baltimore, United States· Withdrawn
Henry Ford Health System Site (014-001)
Verified postcode
Detroit, United States· Recruiting
Infusion Associates
Verified postcode
Grand Rapids, United States· Withdrawn
Mount Sinai Beth Israel Hospital
Verified postcode
New York, United States· Withdrawn
Icahn School of Medicine at Mount Sinai
Verified postcode
New York, United States· Terminated

Common questions

What is hIVIG?

hIVIG stands for anti-COVID-19 hyperimmune intravenous immunoglobulin. It's a special preparation of antibodies from people who have recovered from COVID-19, given through a drip to help your body fight the virus.

What is a placebo?

A placebo is a substance or treatment that looks exactly like the study treatment but doesn't contain any active medicine. It's used to compare against the real treatment to see if the active drug truly makes a difference.

Will I know if I'm getting the real treatment or the placebo?

No, this is a 'double-blind' study. Neither you nor your doctor will know whether you are receiving hIVIG or the placebo. This helps ensure the study results are unbiased.

How long will I be involved in the study?

The main part of the study assessing your COVID-19 symptoms is for seven days after the infusion. However, your overall participation and follow-up will continue for about 28 days.

What happens if my COVID-19 gets worse during the study?

Your health will be closely monitored. If your COVID-19 symptoms worsen or you need hospital care, you will receive the appropriate medical attention as usual.

How to find out more

Rebecca Schoenecker, MPH

webe0376@umn.edu 612-624-5902 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.